Headache pain affects millions of people in the United States each year. While there are a wide assortment of products used to treat headache, ranging from simple analgesics like aspirin and acetaminophen to opiate analgesics such as butorphanol, none of these treatment modalties are invariably effective. All have potentially serious side effects which can greatly limit their usefulness in many subgroups of patients. Consequently, it is desirable to have new alternative headache remedies available in the marketplace.
I have discovered that tricyclic antidepressants usually prescribed orally for relief of mental depression, applied topically to the skin to relieve itching in dermatitis (as described in my prior U.S. Pat. No. 4,395,420, incorporated herein by reference), or applied topically to the mucous membranes of the nose to prevent or treat irritation of the mucous membranes of the nose (as described in my prior U.S. Pat. No. 4,603,131, incorporated herein by reference), are surprisingly effective at preventing the occurrence of headache pain or relieving the pain in subjects experiencing headache pain when applied topically to the nasal mucosa. These compounds include the pharmaceutically acceptable salts of the tricyclics. The term pharmaceutically acceptable salts, as used herein, refers to the physiologically acceptable acid addition salts such as hydrochloride, hydrobromide, hydroiodide, acetate, valerate, oleate, etc. Doxepin, amitriptyline and imipramine respectively are the tertiary amine derivatives of dibenzoxepin, dibenzocycloheptadiene and dibenzazepine wherein the nitrogen atom is connected to the ring structure by a three carbon aliphatic chain and the tertiary amine has two carbon atoms attached thereto in addition to the aliphatic chain.
The present invention relates to a method for topically treating headache pain. The principal object of the present invention is to apply to the nasal mucosa doses of tricyclic antidepressant compounds traditionally employed systemically for the treatment of mental depression to prevent or relieve headache pain.
This and other objects of the present invention may be more readily understood when considered in conjunction with the following detailed description and examples.